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eChalk Talk: CMC Bioanalytical Control for ATMPs-Challenges and Strategies

Sr. Director of CMC Bioanalytical Services, Jeff Patrick, PhD, and Scientific Officer, Michelle Miller, PhD, provide an overview of considerations in the development and lifecycle of assays for CMC control strategies for ATMPs. Watch as they discuss case studies that highlight the development and phase-appropriate validation of tests for potency, purity/impurity, quantity, and identity of ATMP drug products.

Webinar

Considerations for Biodistribution and Viral Shedding Assays in Regulated Bioanalysis

Cell and gene therapies (CGT) are rapidly emerging and evolving as promising therapies for a variety of disease indications. It is important to understand the…

Webinar

Potency Assays For ATMPs — Conception, Development, Validation, Matrixed Approaches And Assay Lifecycle

Advanced therapy medicinal products or ATMPs, are among the fastest growing areas of biotherapeutics, encompassing gene therapies, viral therapies, vaccines and cell therapies. The control…

Webinar

ADA Assessment For Cell Therapies

Featured

Economical Preclinical PK Immunoassay

A start-up biotechnology company developed a library of constructs having the Fc portion of human IgG and their warhead denoted as X for confidential reasons. Fc-X fusion protein drug candidates were distinguished by amino acid substitutions in the warhead moiety, changes that were predicted to affect PK characteristics.

Case Study

Increasing Assay Sensitivity

Case Study

PK Assay For Therapeutic Antibody Quantification In Sodium Heparin Plasma

While conducting the pre-validation stage of a pharmacokinetic assay study, a sponsor asked BioAgilytix to develop a method for analyzing a specific therapeutic antibody when…

Case Study

Use Of MSD-ECL In Support Of Multiplex Biomarker Study

Blog

Unraveling the Biosimilar Paradox

Riding a wave of blockbuster molecule patent expirations, the global biosimilar market grew to nearly $18 billion in 2020. With a total of 26 blockbuster…

Blog

CMC Analytical Control Strategies for Drug Development

CMC (chemistry, manufacturing, and controls) is a term used when drug developers define their investigative drug substance, establish manufacturing methods for…

Blog

Large Molecule Bioanalysis using LC/MS

Introduction to Large Molecules Therapeutics are an ever-evolving landscape of modalities which range in complexity but can be grouped into two broad categories: small molecules…

Blog

LC/MS Applications in Drug Development

Basic Principles of LC/MS Methods Liquid Chromatography-Mass Spectrometry (LC/MS) is a technique that involves the physical separation of target analytes followed by their mass-based detection.…

Podcast

[EPISODE 27] CEO of BioAgilytix Davide Molho, Discusses Passion, Innovation, and the Future of the CRO Industry

In this episode of Molecular Moment, host Jim McNally, Ph.D., welcomes Davide Molho, DVM, the new CEO of BioAgilytix, to discuss his background, interests, and…

Podcast

[Episode 26] Drs. Shashank Gorityala, Ben Nie, and Amanda Hays talk LC/MS bioanalysis, platforms, matrices, workflows, and regulations

Podcast

[EPISODE 25] Adam Stasio Talks Large Data Sets, Breaking Down Problems, and Tech-Driven Solutions

Podcast

[EPISODE 24] Dr. David Berkowitz Talks Enzymes, Radiation, And The Lincoln Marathon

Featured

What is an ADA assay cut-point and how is it determined?

In this episode of “Science in 60” Matt Moore delves into the fascinating world of ADA assay cut-point and how it’s established. ADA assay cut-point is…

Science in 60

What is Luminex and How Does it Work?

Science in 60

How Do You Use MSD U-Plex Assay Technology For Biomarker Multiplexing?

Science in 60

Webinars

eChalk Talk: CMC Bioanalytical Control for ATMPs-Challenges and Strategies

Considerations for Biodistribution and Viral Shedding Assays in Regulated Bioanalysis